Actovegin solution for injection 40mg / ml, 2ml No. 25

• Metabolic and vascular disorders of the brain (including ischemic stroke, traumatic brain injury).

• Peripheral (arterial and venous) vascular disorders and their consequences (arterial angiopathy, trophic ulcers); diabetic polyneuropathy

• Wound healing (ulcers of various etiologies, burns, trophic disorders (bedsores), impaired wound healing processes).

• Prevention and treatment of radiation injuries of the skin and mucous membranes during radiation therapy

Intra-arterial, intravenous, (including in the form of infusion) and intramuscularly. In connection with the potential for the development of anaphylactic reactions, it is recommended to test for the presence of hypersensitivity to the drug before starting the infusion.

1 ampoule contains:
active ingredient: ActoveginЃ concentrate (in terms of dry deproteinized hemoderivat of calf blood) 1) - 80.0 mg;
excipient: water for injection - up to 2 ml.

Hypersensitivity to ActoveginЃ or similar drugs, decompensated heart failure, pulmonary edema, oliguria, anuria, fluid retention in the body.

With caution: hyperchloremia, hypernatremia

Trade name of the drug:

ActoveginЃ

Grouping name

Deproteinized calf blood hemoderivative

Dosage form:

injection

Composition

For ampoules with a volume of 2 ml:

1 ampoule contains:
active ingredient: ActoveginЃ concentrate (in terms of dry deproteinized hemoderivat of calf blood) 1) - 80.0 mg;
excipient: water for injection - up to 2 ml.

For 5 ml ampoules:

1 ampoule contains:
active ingredient: ActoveginЃ concentrate (in terms of dry deproteinized hemoderivat of calf blood) 1) - 200.0 mg;
excipient: water for injection - up to 5 ml.

For 10 ml ampoules:

1 ampoule contains:
active ingredient: ActoveginЃ concentrate (in terms of dry deproteinized hemoderivat of calf blood) 1) - 400.0 mg;
excipient: water for injection - up to 10 ml.

1) The ActoveginЃ concentrate contains sodium chloride in the form of sodium and chlorine ions, which are components of the blood of calves. Sodium chloride is not added or removed during the concentrate production process. The sodium chloride content is about 53.6 mg (for 2 ml ampoules), about 134.0 mg (for 5 ml ampoules) and about 268.0 mg (for 10 ml ampoules).

Description:

clear yellowish solution

Pharmacotherapeutic group:

tissue regeneration stimulant

ATX code:

¬06AB

pharmachologic effect

Pharmacodynamics

Antihypoxant. ActoveginЃ is a hemoderivat that is obtained by dialysis and ultrafiltration (compounds with a molecular weight of less than 5000 daltons pass).

It has a positive effect on the transport and utilization of glucose, stimulates oxygen consumption (which leads to the stabilization of the plasma membranes of cells during ischemia and a decrease in the formation of lactate), thus having an antihypoxic effect, which begins to manifest itself at the latest 30 minutes after parenteral administration and reaches a maximum on average after 3 hours (2-6 hours). ActoveginЃ increases the concentration of adenosine triphosphate, adenosine diphosphate, phosphocreatine, as well as amino acids - glutamate, aspartate and gamma-aminobutyric acid.

The effect of ActoveginЃ on the absorption and utilization of oxygen, as well as insulin-like activity with the stimulation of glucose transport and oxidation, are significant in the treatment of diabetic polyneuropathy (DPN). In patients with diabetes mellitus and diabetic polyneuropathy, ActoveginЃ reliably reduces the symptoms of polyneuropathy (stitching pain, burning sensation, parasthesia, numbness in the lower extremities). Sensory disorders are objectively reduced, and the mental well-being of patients improves.

Pharmacokinet

Using pharmacokinetic methods, it is impossible to study the pharmacokinetic parameters of ActoveginЃ, since it consists only of physiological components that are usually present in the body.

To date, no decrease in the pharmacological effect of hemoderivatives has been found in patients with altered pharmacokinetics (for example, hepatic or renal failure, metabolic changes associated with old age, as well as metabolic features in newborns)

Indications

• Metabolic and vascular disorders of the brain (including ischemic stroke, traumatic brain injury).

• Peripheral (arterial and venous) vascular disorders and their consequences (arterial angiopathy, trophic ulcers); diabetic polyneuropathy

• Wound healing (ulcers of various etiologies, burns, trophic disorders (bedsores), impaired wound healing processes).

• Prevention and treatment of radiation injuries of the skin and mucous membranes during radiation therapy

Contraindications

Hypersensitivity to ActoveginЃ or similar drugs, decompensated heart failure, pulmonary edema, oliguria, anuria, fluid retention in the body.

With caution: hyperchloremia, hypernatremia

Application during pregnancy and lactation:

use of the drug in pregnant women did not cause adverse effects on the mother or fetus. However, when used in pregnant women, the potential risk to the fetus must be taken into account.

Method of administration and dosage

Intra-arterial, intravenous, (including in the form of infusion) and intramuscularly. In connection with the potential for the development of anaphylactic reactions, it is recommended to test for the presence of hypersensitivity to the drug before starting the infusion.

Side effect

Allergic reactions (skin rash, skin flushing, hyperthermia) up to anaphylactic shock.

Interaction with other medicinal products

Currently unknown.

Special instructions
In the case of intramuscular administration, no more than 5 ml is injected slowly. Due to the possibility of an anaphylactic reaction, it is recommended to carry out a test injection (2 ml intramuscularly).
Solution for injection has a slightly yellowish tint. The intensity of the color may vary from one batch to another depending on the characteristics of the starting materials used, but this does not adversely affect the activity of the drug or its tolerance.
Do not use cloudy solution or solution containing particles.
After opening the ampoule, the solution cannot be stored.

Release form

Solution for injection 40 mg / ml.
2, 5, 10 ml of the drug in colorless glass ampoules (type I, Eur. Pharm.) With a breaking point. 5 ampoules in a plastic blister strip packaging. 1 or 5 blisters with instructions for use are placed in a cardboard box. Transparent protective stickers of a round shape with holographic inscriptions and control of the first opening are glued to the pack.

Shelf life

5 years. Do not use after the expiration date.

Storage conditions

At a temperature not exceeding 25 ? C in a dark place. Keep out of the reach of children!

Conditions of dispensing from pharmacies

Prescribed by a doctor.